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Efficacy of an Arabic Articulatory Error Remediation Software Program in Patients With Velopharyngeal Valve Dysfunction:

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04392817
Recruitment Status : Completed
First Posted : May 19, 2020
Last Update Posted : May 20, 2020
Sponsor:
Information provided by (Responsible Party):
Alaa Mamdouh, Alexandria University

Study Description
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Brief Summary:
To develop a remediation software program that is specific for correcting speech errors in patients with velopharyngeal dysfunction in the Arabic language and test its efficacy, on one group comparing pre and post results

Condition or disease Intervention/treatment Phase
Velopharyngeal Insufficiency Articulation Disorders Hypernasality Syndrome Due to Velopharyngeal Weakness Behavioral: Arabic Articulatory Error Remediation software program Not Applicable

Detailed Description:

The study was carried on 40 patients having articulation errors in cases of velopharyngeal valve dysfunction attending the unit of phoniatrics, otorhinolaryngology department, Alexandria University.

The patients met the specified inclusion and exclusion criteria. The patient underwent pre intervention evaluation and 3 parameters were chosen to compare efficacy of the program before and after therapy.

these include auditory perceptual assessment of speech, nasometer test and articulation test.

The patient underwent the remediation software program as individual sessions. then after finishing the therapy, the patients underwent post therapeutic evaluation with the 3 specified criteria

Statistical analysis Was carried out using SPSS statistics software version 23. Quantitative data were tested for normality using the Kolmogorov-Smirnov test. The variables which were normally distributed were described by Mean± SD. The variables which were not normally distributed, were described by median (Min-Max). Qualitative data were expressed by numbers and percentages. The results were calculated at a level of significance of 5% or less.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: a quasi experimental study comparing pre to post therapy intervention in one group
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Formulatin and Application of a Remediation Software Porgram for Correction of Articulatory Errors in Patients With Velopfaryngeal Dysfunction
Actual Study Start Date : January 2, 2018
Actual Primary Completion Date : January 23, 2019
Actual Study Completion Date : February 9, 2019

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: the participating group in the intervention
patient complaining of seppch rerrors due t ovelopharyngeal insufficiency and underwent the intervention
 Behavioral: Arabic Articulatory Error Remediation software program
A speech therapy computerized intervention


Outcome Measures
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Primary Outcome Measures :
  1. change in Arabic articulation test [ Time Frame: base line( pre -intervention) ]
    a qualitative test that define presence or absence of articulation errors

  2. change in Arabic articulation test [ Time Frame: immediately after intervention ]
    a qualitative test that define presence or absence of articulation errors

  3. change in naso meter values [ Time Frame: pre intervention ]
    a device that measure nasalance score as a ratio expressed in percentage between nasal sound energy to nasal plus oral sound in patients pre and post intervention for quantitaive assesment of nasal air emission and nasal tone where the lower values mean beteer results

  4. change in naso meter values [ Time Frame: immediately after intervention ]
    a device that measure nasalance score as a ratio expressed in percentage between nasal sound energy to nasal plus oral sound in patients pre and post intervention for quantitaive assesment of nasal air emission and nasal tone where the lower values mean beteer results

  5. change in Auditory perceptual assessment of speech [ Time Frame: pre intervention ]
    A qualitative scale of patient speech : 5 grade from 0( not present) to 4 (sever)

  6. change in Auditory perceptual assessment of speech [ Time Frame: immediately after intervention ]
    A qualitative scale of patient speech : 5 grade from 0( not present) to 4 (sever)


Secondary Outcome Measures :
  1. effect of the age factor on nasometer values after intervention [ Time Frame: immediately after intervention ]
    statistical tests for correlation

  2. effect of the age factor on auditory perceptual assessment after intervention [ Time Frame: immediately after intervention ]
    statistical tests for correlation

  3. effect of the surgical repair on the nasometer values after intervention [ Time Frame: immediately after intervention ]
    comparison between two groups


Eligibility Criteria
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Ages Eligible for Study:   5 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • clinically presented by articulation errors due to velopharyngeal dysfunction
  • Age of 5 years and above with
  • must have normal hearing and vision.

Exclusion Criteria:

  • Unrepaired cleft palate.
  • Large palatal fistula.
  • Brain damage and intellectual disability.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04392817


Locations
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Egypt
Faculty of Medicine, Alexandria universtiy
Alexandria, Egypt, 21500
Sponsors and Collaborators
Alaa Mamdouh
Investigators
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Study Director: Engy S Elhakeem, PhD Otorhinolaryngology department,Faculty of Medicine, Alexandria University
Study Chair: Reham M Elmaghraby, PhD Otorhinolaryngology department,Faculty of Medicine, Alexandria University
More Information
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Publications:
Kummer AW( 2104) Cleft Palat and Craniofacial Anomalies: Effect on speech and resonance, 3rd edition ed. Delmar Cengage, NY. 23-31 p. .
3. Kirschner RE, Baylis AL(2013) Velopharyngeal dysfunction. In: Neligan PC, Gurtner GC, editors. Plastic Surgery: Principles and practice, 3rd ed. Elsevier Inc, St. Louis. p. 614-30.
Kotby MN, Bassiouny S, El-Zomor M, E M, editors.(1986) Standardization of an Articulation Test (In Arabic). Proceeding of the 9th Annual Ain Shams Medical Congress, Cairo, Egypt.
18. Kotby MN E-SA, Alloush T, Gamal N(1992) 3. Dysarthria Annual Bulletin of Yufuin Kosenenkin Hospital. Hiese. 373-80.

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Responsible Party: Alaa Mamdouh, Assistant lecturer of phoniatrics, Alexandria University
ClinicalTrials.gov Identifier: NCT04392817    
Other Study ID Numbers: 0105440
First Posted: May 19, 2020    Key Record Dates
Last Update Posted: May 20, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: It is not yet known if there will be a palne to make IPD available
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Time Frame: for 6 months after puplishing
Access Criteria: Through the Email Address A_abdelhamed14@alexmed,edu,eg

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Alaa Mamdouh, Alexandria University:
Velopharyngeal dysfunction Hypernasality
Additional relevant MeSH terms:
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Velopharyngeal Insufficiency
Articulation Disorders
Mouth Abnormalities
Mouth Diseases
Stomatognathic Diseases
Pharyngeal Diseases
Stomatognathic System Abnormalities
Otorhinolaryngologic Diseases
 Congenital Abnormalities
Speech Disorders
Language Disorders
Communication Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases